What is Biosafety?
Biosafety is a framework that describes the use of specific practices, training, safety equipment, and facilities to protect workers, the community, local agriculture, and the environment from an accidental exposure or unintentional release of infectious material.
At Sitero Biosafety, we believe in safety first and compliance always. We want to partner with institutions and clinical sites to keep workers and the community safe. We are streamlined and efficient but uncompromising on our commitment to Biosafety. We are technology enhanced with proprietary software to make reviews and compliance easy to manage. Nothing is more important to us than people and communication.
Sitero strives to be a thought leader in Biosafety, giving back to the biosafety profession and the community.
Biosafety Compliance
All Sitero Biosafety complies and conforms with the NIH Guidelines, the 6th edition of the BMBL, WHO and ISO 35001.
We align with Biosafety and Biorisk best practices outlined by evidence, regulation, and professional recommendations. Sitero complies with all local, state, and federal requirements.
Biosafety Services
Biosafety FAQs
Yes, all members of the IBC are required to sign non-disclosure agreements. However, it should be noted that the NIH does require that IBC meetings are open to the public and IBC meeting minutes are subject to FOIA.
Yes, this will be completed in the Sitero Mentor program. This may be conducted virtually or by Sitero staff on-site.
Basic Biosafety (OSHA Bloodborne Pathogen training), spill response, and for staff that ship and receive IATA/DOT certification. The PI will also need training on NIH/IBC basics.
Institutions that fail to comply with the NIH Guidelines risk suspension, loss, or termination of funding for the non-compliant study. They also potentially risk losing financial support for other NIH-funded other projects using r/sNAs or the requirement to obtain NIH approval before commencing future r/sNA research.
The first step is to attempt to correct the immediate problem and then contact your IBC chair or coordinator, who can help you with corrective action suggestions and assist with reporting steps. A complete report of an incident must be forwarded to the NIH within 30 days.
Research or production that involves greater than 10-liter volumes.
In some circumstances, yes, a BSO must be appointed to comply with the NIH Guidelines if the research meets the large-scale or high-risk criteria. The BSO would also serve on the IBC. If you are not working at high-risk levels or large scale, no, a BSO is not required.
The PI’s extended version CV documents PI experience. This should list any clinical trials worked on, clinical investigator and other biosafety training, and peer-reviewed publications.
While the PI cannot be a member of the IBC, they are free to join the IBC meeting to discuss the protocol(s). They would be asked to leave before an IBC vote could occur.
A Sitero Mentor account will be created for your institution and documents can be uploaded to this site. IBC members can access documentation once a meeting has been scheduled. The PI will have access to review status and make changes as needed.
Changes to the study are considered amendments and must be reviewed by the IBC. Initially, the IBC Chair will review any changes and then may administratively approve the amendments or recommend a convened IBC meeting, depending upon whether the changes affect the risk assessment.
After initial IBC approval has been obtained, the committee reviews functional studies annually until the study meets close-out criteria. An IBC meeting may be required sooner than one year if any of the following modifications are made; (i) change to the overseeing PI, (ii) the manner the Investigational agent is handled, (iii) modifications to the dosing strategy, or (iv) the location(s) of IA handling.
IBC review and approval can occur before or after IRB approval. However, clinical research studies involving HGT require approval from both IRB and IBC before the study can commence.
The NIH Guidelines require that IBC meetings are open to the public. You will be asked to post a sign (public posting) that details the date and time of your upcoming IBC meeting. It should also include contact information for someone at your site, typically the study coordinator, whom members of the public can reach if they would like to attend an IBC meeting.
Sitero’s IBC Coordinator will assign an IBC Chair (this is an experienced biosafety professional who has expert knowledge in NIH Guidelines) and other subject matter experts from their staff. The IBC coordinator will also identify local unaffiliated members. You will be asked to identify one-two people who work at your institution to serve on your IBC. They will represent your safety staff, lab staff, and others involved in the study.
Sitero close-out criteria for concluding IBC oversight are that (i) the study must be complete, (ii) the final dosing of the last human subject has been conducted, and (iii) Investigational Agent (IA) is off-site (either destroyed or returned to the sponsor).
While the IBC is required to review all research involving recombinant r/sNAs, it can also oversee any hazardous research if the Institution chooses. This may include research that is not in human subjects, but in animals or in vitro.
For any work that involves work with r/sNAs in human subjects (Section III-C NIH Guidelines), IBC approval must be obtained before research/study is initiated.
